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Activity Outline
FDA Grand Rounds: The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars
January 12, 2023
Virtual - Zoom
FDA Grand Rounds: The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars
January 12, 2023
Virtual - Zoom
Activity Coordinators:
Madison Hanson (Madison.Hanson@fda.hhs.gov), Rokhsareh Shahidzadeh (Rokhsareh.Shahidzadeh@fda.hhs.gov), Sharron Watson (Sharron.Watson@fda.hhs.gov)
Series Description
The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.
Lecture Description
On April 28, 2022, the Food and Drug Administration (FDA) announced proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars. These actions have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction, and increasing the numbers of smokers that quit. This presentation will provide an overview of the scientific evidence that informed the development of these proposed rules, with an explanation of the external peer review process FDA utilized for review of the highly influential scientific assessments for these proposed rules.
On April 28, 2022, the Food and Drug Administration (FDA) announced proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars. These actions have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction, and increasing the numbers of smokers that quit. This presentation will provide an overview of the scientific evidence that informed the development of these proposed rules, with an explanation of the external peer review process FDA utilized for review of the highly influential scientific assessments for these proposed rules.
References
- FDA. “Scientific Review of the Effects of Menthol in Cigarettes on Tobacco Addiction: 1980–2021.” Silver Spring, MD: HHS, FDA, Center for Tobacco Products, 2022. Available at https://www.fda.gov/media/157642/download
- FDA. “Review of Studies Assessing the Potential Impact of Prohibiting Menthol as a Characterizing Flavor in Cigarettes.” Silver Spring, MD: HHS, FDA, Center for Tobacco Products, 2022. Available at https://www.fda.gov/media/157643/download
- FDA. “Scientific Assessment of the Impact of Flavors in Cigar Products.” Silver Spring, MD: HHS, FDA, Center for Tobacco Products, 2022. Available at https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews
Series Objectives
- Discuss the research conducted at the FDA
- Explain how FDA science impacts public health
Learning Objectives After completion of this activity, the participant will be able to:
- Discuss the public health burden of combusted tobacco product use
- Describe the major conclusions of the scientific assessments developed by FDA to inform the proposed product standards
- Discuss the steps involved in the external peer review of the Agency’s scientific assessments
Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.
Agenda
Lecture 1 January 12, 2023
Lecture 1 January 12, 2023
| Time | Topic | Speaker |
|---|---|---|
| 12:00 - 1:00 PM EST | The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars | Bridget Ambrose, PhD, MPH |
Continuing Education Accreditation
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-23-002-L99-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit
Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.
Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure
Faculty
Planning Committee
CE Consultation and Accreditation Team
Faculty
- Ambrose, Bridget, PhD, MPH, Director, Division of Population Health Science, FDA Center for Tobacco Products - nothing to disclose
Planning Committee
- Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
- Pfundt, Tiffany, PharmD, Program Coordinator, FDA/CDER/OTBB - nothing to disclose
- Wheelock, Leslie, RN, MS, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose
CE Consultation and Accreditation Team
- Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Registration is complimentary; therefore refunds are not applicable.
U.S. Food and Drug Administration